search
Back to results

Buccal Mucosal Graft for the Repair of Iatrogenic Pelviureteric Junction Obstruction or Ureteric Stricture.

Primary Purpose

Pelvi Ureteric Junction Obstruction or Ureteral Stricture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
buccal mucosal graft to repair iatrogenic PUJO
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvi Ureteric Junction Obstruction or Ureteral Stricture

Eligibility Criteria

undefined - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- any patient with iatrogenic pelviureteric junction obstruction or long segment ureteric stricture

Exclusion Criteria:

  • elderly patients unfit for general anaesthesia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients with iatrogenic PUJO

    Arm Description

    patients with iatrogenic PUJO or long segment ureteric stricture disease for safety and efficacy of using buccal graft for repair

    Outcomes

    Primary Outcome Measures

    Number of Participants with patent renal pelvis and ureter after surgery.
    3 months after surgery Diuretic renography will be done to judge patency of the pelvis and ureter and resolution of hydronephrosis

    Secondary Outcome Measures

    Full Information

    First Posted
    August 3, 2020
    Last Updated
    August 6, 2020
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04503330
    Brief Title
    Buccal Mucosal Graft for the Repair of Iatrogenic Pelviureteric Junction Obstruction or Ureteric Stricture.
    Official Title
    Using Buccal Mucosal Graft as an Augmention Graft for Complex Cases of Iatrogenic Pelviureteric Junction Obstruction and Long Segment Ureteric Stricture Disease.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    November 1, 2021 (Anticipated)
    Study Completion Date
    December 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Prospective study to evaluate the safety and efficacy of using buccal mucosal graft for repairing complex cases of iatrogenic pelvi ureteric junction obstruction and long segment ureteric stricture disease.
    Detailed Description
    A graft of buccal mucosa will be used to augment either the narrow unhealthy pelviureteric junction or a narrow long segment of the ureter. after freeing the narrowed part, a posterior incision will be made in the ureter or renal pelvis then the graft will be implanted on the psoas muscle using interrupted sutures in a position the allows easy anastomosis to the ureter or renal pelvis. Alternatively a lateral incision in the renal pelvis or the ureter may be done for the graft anastomosis and then surrounded with omenal flap to ensure a good blood supply for the graft.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvi Ureteric Junction Obstruction or Ureteral Stricture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    20 patients with iatrogenic pelviureteric junction obstruction or ureteric stricture disease
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with iatrogenic PUJO
    Arm Type
    Experimental
    Arm Description
    patients with iatrogenic PUJO or long segment ureteric stricture disease for safety and efficacy of using buccal graft for repair
    Intervention Type
    Procedure
    Intervention Name(s)
    buccal mucosal graft to repair iatrogenic PUJO
    Intervention Description
    Augmented buccal mucosal graft anastomosis to repair iatrogenic PUJO or long segment ureteric stricture disease
    Primary Outcome Measure Information:
    Title
    Number of Participants with patent renal pelvis and ureter after surgery.
    Description
    3 months after surgery Diuretic renography will be done to judge patency of the pelvis and ureter and resolution of hydronephrosis
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - any patient with iatrogenic pelviureteric junction obstruction or long segment ureteric stricture Exclusion Criteria: elderly patients unfit for general anaesthesia.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    study protocol statistical analysis results
    IPD Sharing Time Frame
    June 2021
    IPD Sharing Access Criteria
    through clinical trials webpage

    Learn more about this trial

    Buccal Mucosal Graft for the Repair of Iatrogenic Pelviureteric Junction Obstruction or Ureteric Stricture.

    We'll reach out to this number within 24 hrs